Mylan Fentanyl Transdermal System CII

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IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse
Fentanyl Transdermal System exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Fentanyl Transdermal System, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse
Fentanyl Transdermal System exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Fentanyl Transdermal System, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Transdermal System. Monitor for respiratory depression, especially during initiation of Fentanyl Transdermal System or following a dose increase. Because of the risk of respiratory depression, Fentanyl Transdermal System is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain [see Contraindications (4) and Warnings and Precautions (5.2)].

Accidental Exposure
Accidental exposure to even one dose of Fentanyl Transdermal System, especially in children, can result in a fatal overdose of fentanyl. Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to Fentanyl Transdermal System. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure [see Warnings and Precautions (5.3)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of Fentanyl Transdermal System during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)].

Cytochrome P450 3A4 Interaction
The concomitant use of Fentanyl Transdermal System with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Transdermal System and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)].

Risk of Increased Fentanyl Absorption with Application of External Heat
Exposure of the Fentanyl Transdermal System application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources [see Warnings and Precautions (5.6)].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.7), Drug Interactions (7)].

  • Reserve concomitant prescribing of Fentanyl Transdermal System and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit treatment to the minimum effective dosages and durations.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Fentanyl Transdermal System is contraindicated in:

  • patients who are not opioid-tolerant
  • the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.
  • the management of post-operative pain, including use after out-patient or day surgeries.
  • the management of mild pain.
  • patients with significant respiratory depression.
  • patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
  • patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
  • patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system.

Fentanyl Transdermal System is a modified-release product that delivers the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present. It also exposes users to the risks of addiction, abuse, and misuse. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Fentanyl Transdermal System, and monitor all patients for the development of these behaviors and conditions.

Abuse or misuse of Fentanyl Transdermal System by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Fentanyl Transdermal System.

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

Fentanyl Transdermal System is indicated only in opioid tolerant patients because of the risk for respiratory depression and death. The risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression within the first 24-72 hours of initiating therapy with and following dosage increases of Fentanyl Transdermal System. Proper dosing and titration are essential. Overestimating the first dosage when converting patients from another opioid product can result in fatal overdose.

A considerable amount of active fentanyl remains in Fentanyl Transdermal System even after use as directed. Death, respiratory depression and other serious medical problems have occurred when children and adults were accidentally exposed to Fentanyl Transdermal System. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental secondary exposure of children and others to Fentanyl Transdermal System.

Prolonged use of Fentanyl Transdermal System during pregnancy can result in opioid withdrawal in the neonate that may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Advise pregnant women of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Concomitant use or discontinuation of Cytochrome P450 34A inhibitors or inducers can affect plasma concentrations of fentanyl. Concomitant use with inhibitors can lead to potentially fatal respiratory depression and concomitant use with inducers can result in withdrawal syndrome. Monitor affected patients closely at frequent intervals and consider dosage adjustments according to patient response.

Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources.

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Fentanyl Transdermal System with benzodiazepines and/or other CNS depressants, including alcohol. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use to meet treatment goals.

Advise patients and caregivers about the risks of respiratory depression and sedation when used in combination with benzodiazepines or other CNS depressants. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.

Serum fentanyl concentrations could theoretically increase by approximately one-third for patients with a body temperature of 40°C (104°F). In the event of a fever, closely monitor patients for sedation and respiratory depression and reduce the Fentanyl Transdermal System dose, if necessary. Warn patients to avoid strenuous exertion that leads to increased core body temperature while wearing Fentanyl Transdermal System to avoid the risk of potential overdose and death.

Patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Fentanyl Transdermal System. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of Fentanyl Transdermal System with serotonergic drugs. The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue Fentanyl Transdermal System immediately if serotonin syndrome is suspected.

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is suspected, confirm the diagnosis as soon as possible and if confirmed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.

Fentanyl Transdermal System may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs. Avoid use in patients with circulatory shock. Fentanyl Transdermal System may cause vasodilation that can further reduce cardiac output and blood pressure.

Avoid the use of Fentanyl Transdermal System in patients with impaired consciousness or coma. In patients with increased intracranial pressure, brain tumors or head injury, Fentanyl Transdermal System may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Fentanyl Transdermal System.

Fentanyl Transdermal System may produce bradycardia. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with Fentanyl Transdermal System.

Avoid the use of Fentanyl Transdermal System in patients with severe hepatic impairment or severe renal impairment. Insufficient information exists to make precise dosing recommendations regarding the use of Fentanyl Transdermal System in patients with impaired hepatic or impaired renal function. Therefore, to avoid starting patients with mild to moderate hepatic impairment or renal impairment on too high of a dose, start with one half of the usual dosage of Fentanyl Transdermal System.

Fentanyl may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during therapy with Fentanyl Transdermal System.

Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Fentanyl Transdermal System. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

In clinical studies, the most common adverse reactions (≥5%) reported for patients treated with Fentanyl Transdermal System were nausea, vomiting, somnolence, headache, dizziness, insomnia, diarrhea, constipation, hyperhidrosis, fatigue, feeling cold, and anorexia.

Click here for full Prescribing Information, including Boxed WARNING, Instructions for Use and Medication Guide.

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